Regulatory Material definition

Regulatory Material means any and all regulatory applications, submissions, notifications, communications, correspondences, registrations, and other filings made to, received from, or otherwise conducted with a Regulatory Authority in order to Develop, manufacture, market, sell, or otherwise Commercialize a pharmaceutical or biologic product in a particular country or jurisdiction, including IND, XXXx, and Regulatory Approvals.

Regulatory Material means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Product.

Regulatory Material means any documentation drawn up by the Agency pursuant to Article 14(2) of Regulation (EC) No 1592/2002.

Examples of Regulatory Material in a sentence

• All Required Consents (including, in each case, the expiration or termination of the waiting periods (and any extensions thereof) applicable to the Merger and the transactions contemplated by this Agreement) shall have been obtained and shall have become Final Orders and such Final Orders shall not impose terms or conditions that, individually or in the aggregate, could reasonably be expected to have a Regulatory Material Adverse Effect.

• All Transaction Approvals shall have been filed, have occurred or been obtained and shall be in full force and effect or the waiting periods applicable thereto shall have terminated or expired, in each case, without any Regulatory Material Adverse Effect.

• Any Party seeking to claim that a condition to its obligation to effect the transactions contemplated hereby has not been satisfied by reason of the fact that a Material Adverse Effect or a Regulatory Material Adverse Effect has occurred or would reasonably be expected to occur or result will have the burden of proof to establish that occurrence or expectation.

• None of the Required Governmental Consents or any other Governmental Consents required under applicable Law in connection with the consummation of the Mergers shall have imposed any Regulatory Actions that, individually or in the aggregate, would be reasonably likely to have a Regulatory Material Adverse Effect.

• Spark shall promptly share all Regulatory Material it receives in writing from a Regulatory Authority with Selecta that relates to a Licensed Particle.

More Definitions of Regulatory Material

Regulatory Material means regulatory applications and authorizations or clearances (including INDs), correspondence, records, filings, submissions, registrations or other filings made to, received from or otherwise conducted with the FDA (including minutes of meetings with the FDA) or any other regulatory authority.

Regulatory Material means regulatory submissions and approvals including, without limitation, clinical trial data, Toxicology and Bioavailability Studies, IND, NDA, clinical trial exemption, governmental pricing approvals, and any other foreign equivalents to the extent such material is generated under this Agreement and is solely related to the Field.

Regulatory Material means either of the following: proposals from EASA to the European Commission for amendments to the Basic Regulation and to the delegated and implementing acts to be adopted on the basis thereof, certification specifications or other detailed specifications, acceptable means of compliance, or guidance material;

Regulatory Material means all of the following, in each case solely to the extent related to the Compounds, and any product containing any Compound, that are owned, in the possession or under the control of Seller or any of its Affiliates (and intellectual property and proprietary rights in or associated therewith): (i) technological, scientific, development, chemical, biological, pharmacological, toxicological, regulatory, R&D notebooks and related materials, (ii) batch records, stability records, methods and other records and information required to support the manufacture, composition, use, distribution, marketing, promotion, sale, administration or formulation of the Compounds, (iii) product safety related information and all other adverse event, complaint files and other reports and information relating to the Compounds or any product containing any Compound(s), (iv) written correspondence with any other Regulatory Authority and all supporting documents with respect thereto and (v) other data, files, records and other information (in any form or medium, wherever located) similar to the foregoing.

Regulatory Material means regulatory applications (including the NDA Amendment), submissions, notifications, communications, correspondence, registrations, NDA Approval or other filings made to, received from or otherwise conducted with the FDA(including minutes of meeting with the FDA) that are necessary or relate to the Development, Manufacture or Commercialization of Product for the Licensed Territory.

Regulatory Material means any and all regulatory applications, submissions, notifications, communications, correspondences, registrations, and other filings made to, received from, or otherwise conducted with a Regulatory Authority in order to Develop, manufacture, market, sell, or otherwise Commercialize a pharmaceutical, biologic, or medical device product or any combination thereof in a particular country or jurisdiction, including IDEs, INDs, MAAs, and Regulatory Approvals.

Regulatory Material means regulatory applications (including the IND and NDA), submissions, notifications, communications, correspondence, registrations (including the NDA Approval) or other filings made to, received from or otherwise conducted with the FDA (including minutes of meetings with the FDA) that are Controlled by DURECT and are necessary or reasonably useful to Exploit Licensed Product in the Licensed Territory.